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Blood, 21 May 2009, Vol. 113, No. 21, pp. 5074-5082. Prepublished online as a Blood First Edition Paper on March 6, 2009; DOI 10.1182/blood-2009-02-202937. This Article Full Text (PDF) Supplemental Tables All Versions of this Article: blood-2009-02-202937v1 113/21/5074    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Martin, P. J. Articles by Weisdorf, D. Search for Related Content PubMed PubMed Citation Articles by Martin, P. J. Articles by Weisdorf, D. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted February 2, 2009 Accepted February 28, 2009 Evaluation of mycophenolate mofetil for initial treatment of chronic graft-versus-host disease Paul J. Martin*, Barry E. Storer, Scott D. Rowley, Mary E.D. Flowers, Stephanie J. Lee, Paul A. Carpenter, John R. Wingard, Paul J. Shaughnessy, Marcel P. DeVetten, Madan Jagasia, Joseph W. Fay, Koen van Besien, Vikas Gupta, Carrie Kitko, Laura J. Johnston, Richard T. Maziarz, Mukta Arora, Pamala A. Jacobson, and Daniel Weisdorf Fred Hutchinson Cancer Research Center, Seattle, WA, United States Department of Biostatistics, University of Washington, Seattle, WA, United States Hackensack University Medical Center, Hackensack, NJ, United States Department of Medicine, University of Washington, Seattle, WA, United States Department of Pediatrics, University of Washington, Seattle, WA, United States University of Florida, Gainesville, FL, United States Texas Transplant Institute, San Antonio, TX, United States University of Nebraska, Omaha, NE, United States Vanderbilt University, Nashville, TN, United States Baylor University Medical Center at Dallas, Dallas, TX, United States University of Chicago, Chicago, IL, United States Princess Margaret Hospital, Toronto, Ontario, Canada University of Michigan, Ann Arbor, MI, United States Stanford University, Palo Alto, CA, United States Oregon Health and Science University, Portland, OR, United States University of Minnesota, Minneapolis, MN, United States * Corresponding author; email: pmartin{at}fhcrc.org. Mycophenolate mofetil (MMF) has become a preferred choice for treatment of steroid-refractory chronic graft-versus-host disease (GVHD). We conducted a double-blind, randomized multi-center trial to determine whether the addition of MMF improves the efficacy of initial systemic treatment of chronic GVHD. The primary endpoint was resolution of chronic GVHD and withdrawal of all systemic treatment within 2 years, without secondary treatment. Enrollment of 230 patients was planned, providing 90% power to observe a 20% difference in success rates between the two arms. The study was closed after 4 years, because the interim estimated cumulative incidence of success for the primary endpoint was 23% among 74 patients in the MMF arm and 18% among 77 patients in the control arm, indicating a low probability of positive results for the primary endpoint after completing the study as originally planned. Analysis of secondary endpoints showed no evidence of benefit from adding MMF to the systemic regimen first used for treatment of chronic GVHD. The estimated hazard ratio of death was 1.99 (95% confidence interval, 0.9 - 4.3) among patients in the MMF arm compared to the control arm. MMF should not be added to the initial systemic treatment regimen for chronic GVHD. The trial was registered at ClinicalTrials.gov with identifier NCT00089141 on August 4, 2004 CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: D. A. Jacobsohn, A. L. Gilman, A. Rademaker, B. Browning, M. Grimley, L. Lehmann, E. R. Nemecek, K. Thormann, K. R. Schultz, and G. B. Vogelsang Evaluation of pentostatin in corticosteroid-refractory chronic graft-versus-host disease in children: a Pediatric Blood and Marrow Transplant Consortium study Blood, November 12, 2009; 114(20): 4354 - 4360. [Abstract] [Full Text] [PDF]

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